TOFO Insulin Combination Trial
2017年10月10日 更新者：Sanofi
A Randomized, Double Blind Placebo Controlled 2-Arm Parallel Group, Multicenter Study With A 16-Week Treatment Assessing The Efficacy And Safety, And 52-Week Long Term Safety Including 36-Week Open Label Extension Of Tofogliflozin With Insulin Treatment In Type 2 Diabetes Mellitus
Primary Objectives:
To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.
To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.
Secondary Objectives:
To assess the effects of tofogliflozin in comparison to placebo on:
- Body weight
- Fasting plasma glucose (FPG)
- Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.
研究概览
详细说明
The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.
研究类型
介入性
注册 (实际的)
211
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Adachi-ku、日本
- Investigational Site Number 392-028
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Atsugi-shi、日本
- Investigational Site Number 392-007
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Chuoh-ku、日本
- Investigational Site Number 392-026
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Fukuoka-shi、日本
- Investigational Site Number 392-021
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Ichihara-shi、日本
- Investigational Site Number 392-002
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Iruma-shi、日本
- Investigational Site Number 392-012
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Kawaguchi-shi、日本
- Investigational Site Number 392-003
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Kitakyusyu-shi、日本
- Investigational Site Number 392-014
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Kobe-shi、日本
- Investigational Site Number 392-027
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Koga-shi、日本
- Investigational Site Number 392-004
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Kunitachi-shi、日本
- Investigational Site Number 392-022
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Kurume-shi、日本
- Investigational Site Number 392-019
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Kyoto-shi、日本
- Investigational Site Number 392-001
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Kyoto-shi、日本
- Investigational Site Number 392-024
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Matsudo-shi、日本
- Investigational Site Number 392-006
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Mito-shi、日本
- Investigational Site Number 392-008
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Musashino-shi、日本
- Investigational Site Number 392-030
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Okayama-shi、日本
- Investigational Site Number 392-029
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Otsu-shi、日本
- Investigational Site Number 392-017
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Sagamihara-shi、日本
- Investigational Site Number 392-011
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Sakai-shi、日本
- Investigational Site Number 392-020
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Sapporo-shi、日本
- Investigational Site Number 392-010
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Sendai-shi、日本
- Investigational Site Number 392-016
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Shinjuku-ku、日本
- Investigational Site Number 392-018
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Shizuoka-shi、日本
- Investigational Site Number 392-005
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Suita-shi、日本
- Investigational Site Number 392-031
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Sumida-ku、日本
- Investigational Site Number 392-015
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Sunto-gun、日本
- Investigational Site Number 392-023
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Tokorozawa-shi、日本
- Investigational Site Number 392-013
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Yokohama-shi、日本
- Investigational Site Number 392-025
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
- Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
- Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
- Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
- Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
- Body mass index (BMI) ≥18.5 kg/m^2 and <35.0 kg/m^2.
- No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.
Exclusion criteria:
- Type 1 diabetes mellitus.
- Pregnancy or lactation.
- Severely uncontrolled glycemic situation.
- History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
- History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
- A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
- Has previously received treatment with the investigational product.
- Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
- Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical [skin] application, eye drops and sprays).
- Patients who are frequently experiencing orthostatic hypotension.
- Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
- Lipid-lowering drug
- Antihypertensive drug
- Thyroid hormone preparation
- Uric acid lowering drug
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：tofogliflozin
Tofogliflozin administered once daily for 52 weeks.
Insulin administered as base treatment.
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Pharmaceutical form:tablet Route of administration: oral
其他名称：
Pharmaceutical form:solution Route of administration: subcutaneous
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安慰剂比较：placebo
Placebo administered once daily for 16 weeks.
After 16-weeks, Tofogliflozin administered once daily for 36 weeks.
Insulin administered as base treatment.
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Pharmaceutical form:tablet Route of administration: oral
其他名称：
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:tablet Route of administration: oral
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Change in HbA1c from baseline
大体时间：16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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次要结果测量
结果测量 |
大体时间 |
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Change of Body Weight (BW) from baseline
大体时间：16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of FPG from baseline
大体时间：16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Change of PPG from baseline
大体时间：16 weeks after first intake of investigational product
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16 weeks after first intake of investigational product
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Number of subjects with adverse events
大体时间：Up to 52 weeks from the first intake of investigational medicinal product
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Up to 52 weeks from the first intake of investigational medicinal product
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年6月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2014年7月23日
首先提交符合 QC 标准的
2014年7月23日
首次发布 (估计)
2014年7月25日
研究记录更新
最后更新发布 (实际的)
2017年10月11日
上次提交的符合 QC 标准的更新
2017年10月10日
最后验证
2017年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- TOFOGL07061
- U1111-1159-5316 (UTN)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.